Regulatory Affairs Consultant / Senior Consultant - Labeling - Remote
Company: PAREXEL
Location: Opa Locka
Posted on: June 25, 2022
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Job Description:
INCREDIBLE HOME-BASED OPPORTUNITY DEDICATED TO ONE CLIENT If you
passionate about labeling, have a passion for Regulatory Affairs,
and are looking for an opportunity to work with an amazing team,
then Parexel's Consulting has the perfect opportunity for you
Parexel---s Consulting Team is expanding, and we are seeking a
Senior/Consultant, Regulatory Labeling to partner with our global
client on US related labeling activities As a Senior/Consultant,
Regulatory Labeling, you will partner with Label Strategist to:
Conduct international labeling operations activities to support
global new product and supplemental applications to product
registration, and post approval launches for impacted international
markets. Collaborate with Technical Operations team members to
ensure commercial distribution, Regulatory Technology for labeling
submissions, PV for safety reporting, and other functional groups.
Provide labeling to Advertising and Promotion for marketing pieces,
and with Commercial for website postings if needed. Work with
Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for
labeling distribution, tracking and quality control. Utilize
regulatory/product knowledge to provide operational support to
ensure that labeling materials meet regulatory and company
requirements and timelines. You will also: Be responsible for
executing and effective quality control reviews and tracking
(primarily) internally used labeling documents (Core Data Sheet,
Core Patient Information Leaflet, Core Instructions for Use) and
outward facing local/regional labeling (USPI, Med Guide, SmPC, PIL,
Canadian Product Monograph, Instructions for Use) as well as
container and carton labels to meet regional regulatory
requirements and ensure consistency between labeling, labels and
supportive documents. Act as operational expert for the Global
Labeling tracking in RIMs, SPL generation, ensure development and
maintenance of templates, collaboration features and system
upgrades. Contribute to the continuous improvement of the
end-to-end labeling process including excellent
proofreading/editing skills and compiling supportive documentation.
Support labeling inspection / audit readiness activities
Qualifications Education and Experience Bachelor---s Degree plus at
least 4 years of experience in drug development especially in
labeling, product package coordination, clinical
supplies/packaging, supply chain regulatory affairs, or quality.
Exceptional candidates with 3 years of labeling related experience
may also be considered Good working knowledge of key labeling
regulations/guidance and past experience in label development
(CCDS, USPI, packaging) The ability to research and create
comparator labeling documents Strong understanding and past
experience creating annual reports The ability to collaborate with
Tech Ops for artwork implementation Proficiency in SPL (all
aspects, types and troubleshooting) and the ability to manage the
review and approval of labeling in a document management system.
Electronic document management systems use and / or electronic
submission experience Knowledge and Skills Strong attention to
detail Solid understanding and interpretation of US labeling
regulatory requirements preferred Solid understanding of
requirements for tracking of labeling updates Solid understanding
of the pharmaceutical industry drug development process and
willingness to learn global labeling regulatory requirements and
industry practice Solid aptitude for use of IT systems; Regulatory
Information Management System (RIMS), electronic document
management system (EDMS), Proficiency in MS Office suite; Willing
to learn additional applications Understanding of label development
and submission processes preferred. Ability to recognize and
escalate issues Strong written and oral communication and
organizational skills Ability to generate and initiate problem
solving innovative solutions The ideal candidate should be action
oriented, customer focused, ability to manage workloads and set
priorities. In addition, he/she should be capable of dealing with
ambiguity, be creative, be comfortable working with multifunctional
teams This is a home-based role; however, in the future 15%
domestic / international travel may be required to client offices
coupled with flexibility to travel to Parexel's offices for
team/client meetings Employment is contingent on disclosure of your
COVID-19 vaccination status and, if relevant, proof of vaccination.
EEO Disclaimer Parexel is an equal opportunity employer. Qualified
applicants will receive consideration for employment without regard
to legally protected status, which in the US includes race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.
Keywords: PAREXEL, Miami , Regulatory Affairs Consultant / Senior Consultant - Labeling - Remote, Professions , Opa Locka, Florida
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